The Effectiveness of Individual Placement and Support in Chronic Pain Patients (IPSinPain)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
IPS
Self-help
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Patients referred to the pain clinic and eligible for interdisciplinary treatment
- Not currently working (long-term sick leave, disability pension or unemployed)
- Expressed desire to work
Exclusion Criteria:
- Living too far away from the pain clinic (outside of Oslo)
Sites / Locations
- Silje Endresen Reme
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as usual + self-help
Treatment as usual + IPS
Arm Description
Interdisciplinary treatment as usual at the outpatient pain clinic + an additional self-help binder with resources about pain management and employment advice.
Individual job support (IPS) as an integrated part of the interdisciplinary treatment at the outpatient pain clinic.
Outcomes
Primary Outcome Measures
Competitive employment
Hours/days/weeks worked in competitive employment the last 12 months
Secondary Outcome Measures
Health-related quality of life
EQ5D termometer
Pain-related disability
Oswestry, modified to chronic pain patients
Pain intensity
Numeric Rating Scale
Full Information
NCT ID
NCT02697656
First Posted
January 18, 2016
Last Updated
June 8, 2021
Sponsor
Oslo University Hospital
Collaborators
Norwegian Directorate of Health, Norwegian Labour and Welfare Administration
1. Study Identification
Unique Protocol Identification Number
NCT02697656
Brief Title
The Effectiveness of Individual Placement and Support in Chronic Pain Patients
Acronym
IPSinPain
Official Title
A Randomized Controlled Trial Assessing the Effectiveness of the Individual Placement and Support Model for Patients With Chronic Pain in an Outpatient Hospital Pain Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Directorate of Health, Norwegian Labour and Welfare Administration
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but has never previously been tested for patients with chronic pain. In fact, employment support is rarely provided in pain clinics, despite an increasing focus on integrating work and health in all patient treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic.
Detailed Description
Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. IPS represents a relatively new approach to vocational rehabilitation and incorporates following principles: (1) Every person that wants to work, can work given that the person is provided with the appropriate work and environment. (2)The goal is employment in regular, competitive employment. (3) IPS is integrated with treatment. (4) Job search is individualised; based on the participants' preferences and competence. (5) Work incentives planning is provided; which includes counselling about how work can influence social security and other public benefits. The intention of this benefits counselling is to enable the participant to make informed decisions about work (job starts and changes). (6) The job support is not time-limited. (7) Finally, IPS differs from more traditional employment services in that it does not involve pre-vocational training, often referred to as "train, then place". (8) In IPS job search starts as soon as the client expresses an interest in work. Therefore, IPS follows the principle "place, then train".
The effectiveness of IPS for patients with severe mental illness is well documented. International research shows that IPS is more effective than other types of employment programs for this group of clients. However, the effect of IPS on patients with chronic pain in an outpatient hospital clinic is largely unknown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual + self-help
Arm Type
Active Comparator
Arm Description
Interdisciplinary treatment as usual at the outpatient pain clinic + an additional self-help binder with resources about pain management and employment advice.
Arm Title
Treatment as usual + IPS
Arm Type
Experimental
Arm Description
Individual job support (IPS) as an integrated part of the interdisciplinary treatment at the outpatient pain clinic.
Intervention Type
Behavioral
Intervention Name(s)
IPS
Intervention Description
Individualized job support provided by an employment specialist
Intervention Type
Behavioral
Intervention Name(s)
Self-help
Intervention Description
Self-help resources on obtaining employment and coping with chronic pain
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Transdisciplinary treatment at the pain clinic. This includes medical, psychological and physiotherapy treatment.
Primary Outcome Measure Information:
Title
Competitive employment
Description
Hours/days/weeks worked in competitive employment the last 12 months
Time Frame
At 12-months follow-up
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
EQ5D termometer
Time Frame
6 and 12 months follow-up
Title
Pain-related disability
Description
Oswestry, modified to chronic pain patients
Time Frame
6 and 12 months follow-up
Title
Pain intensity
Description
Numeric Rating Scale
Time Frame
6 and 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred to the pain clinic and eligible for interdisciplinary treatment
Not currently working (long-term sick leave, disability pension or unemployed)
Expressed desire to work
Exclusion Criteria:
Living too far away from the pain clinic (outside of Oslo)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silje E Reme, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silje Endresen Reme
City
Oslo
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23161326
Citation
Bond GR, Drake RE. Making the case for IPS supported employment. Adm Policy Ment Health. 2014 Jan;41(1):69-73. doi: 10.1007/s10488-012-0444-6.
Results Reference
background
PubMed Identifier
18407876
Citation
Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290.
Results Reference
background
PubMed Identifier
35234931
Citation
Sveinsdottir V, Jacobsen HB, Ljosaa TM, Linnemorken LTB, Knutzen T, Ghiasvand R, Reme SE. The Individual Placement and Support (IPS) in Pain Trial: A Randomized Controlled Trial of IPS for Patients with Chronic Pain Conditions. Pain Med. 2022 Sep 30;23(10):1757-1766. doi: 10.1093/pm/pnac032.
Results Reference
derived
PubMed Identifier
29433493
Citation
Linnemorken LTB, Sveinsdottir V, Knutzen T, Rodevand L, Hernaes KH, Reme SE. Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain. BMC Musculoskelet Disord. 2018 Feb 13;19(1):47. doi: 10.1186/s12891-018-1962-5.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/29433493
Description
The Study Protocol
Learn more about this trial
The Effectiveness of Individual Placement and Support in Chronic Pain Patients
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